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FDA Warns About Unapproved Product, Melanotan II

FDA is advising consumers to stop using Melanotan II, an unapproved product. Melanotan II is being advertised as a tanning agent, with additional claims of being effective in protecting against skin cancer and rosacea (a flushing and redness of the skin). At the same time, consumers are advised to consult their health care providers if they have experienced any adverse side effects they suspect are related to using the product.

The agency also has issued a Warning Letter to the owner of the company, who is illegally selling and marketing Melanotan II from his Web site.

Problems with Melanotan II

• Claims being made cause the product to be classified as both a drug and a new drug, under the Federal Food, Drug and Cosmetic Act.
• However, the product does not have an approved new drug application.
• There is no evidence that the product is generally recognized as safe and effective for its labeled uses.
• Product's introduction and delivery into interstate commerce violates federal law.
• Risks run by patients who use unapproved new drugs could include adverse side effects from inappropriately prescribed medications, dangerous drug interactions, and harm from contaminated, counterfeit or outdated drugs.

Consumers and health care providers should notify FDA of any complaints or problems associated with this product through the agency's voluntary reporting program: www.fda.gov/medwatch/report.htm or by phone: 1-800-332-1088.

FDA's Warning Letter is available at www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm

Date Posted: Sept. 5, 2007

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